Overview

Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects

Status:
Not yet recruiting

Trial end date:
2022-12-01

Target enrollment:

Participant gender:

Summary

This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in a fed or fasted state to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days.

Phase:

Phase 1

Details

Lead Sponsor:

Virogenics, Inc.

Collaborators:

Celerion
National Institute on Aging (NIA)